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Combination therapy for HCV infection

a technology of conjugation therapy and hcv infection, which is applied in the field of therapeutic combinations, can solve the problems of poor response rate, chronic liver infection, and inability to fully clear the virus of hcv infection, and achieve the effects of improving the survival rate of patients, reducing the risk of infection, and improving the survival ra

Inactive Publication Date: 2005-05-26
VERTEX PHARMA INC
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0110] More than 80% of patients in the third group, who received ribavirin, Peg-Intron, and VX-497 in dosages according to the present invention, achieved undetectable levels of HCV RNA at the end of 24 weeks.

Problems solved by technology

However, at least 85% of patients infected with HCV do not fully clear the virus and develop chronic infection of the liver.
The response rate was relatively poor with only 20% of patients achieving a sustained virological response (SVR) following six months of therapy.
The lack of durable antiviral response along with the need for injections, and the various side effects of the agent (including flu-like syndrome, nausea, anorexia, insomnia and depression) have limited the use of the therapy.
Additionally, ribavirin treatment only minimally and transiently decreases serum HCV RNA levels.
In addition, it has been suggested that hemolysis may damage the liver by increasing iron absorption.

Method used

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  • Combination therapy for HCV infection

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[0109] A 24-week, double blind, randomized, placebo controlled study was conducted on 31 patients that were non-responders to ribavirin / Peg-Intron therapy. The patients were divided into three groups. All three groups received ribavirin / Peg-Intron therapy. One group was administered a placebo, while a second group was administered VX-497 25 mg bid. The third group was administered VX-497 in a dosage according to the present invention.

[0110] More than 80% of patients in the third group, who received ribavirin, Peg-Intron, and VX-497 in dosages according to the present invention, achieved undetectable levels of HCV RNA at the end of 24 weeks.

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Abstract

The present invention relates to therapeutic combinations comprising VX-497, ribavirin, and interferon. The present invention also relates to methods using the therapeutic combinations of the present invention for treating HCV infection or alleviating one or more symptoms thereof in a patient. The present invention also provides kits comprising the combinations of the present invention.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application claims the benefit under 35 U.S.C. § 119 of U.S. Provisional patent application No. 60 / 510,733, filed Oct. 11, 2003, the entire contents of the application being incorporated herein by reference.TECHNICAL FIELD OF THE INVENTION [0002] The present invention relates to therapeutic combinations comprising VX-497, ribavirin, and interferon. The present invention also relates to methods using the therapeutic combinations of the present invention for treating HCV infection or alleviating one or more symptoms thereof in a patient. The present invention also provides kits comprising the therapeutic combinations of the present invention. The present invention also provides a pharmaceutical regimen for administering the therapeutic combinations of the present invention. BACKGROUND OF THE INVENTION [0003] HCV is a RNA virus of the Flaviviridae family. Acute infection with HCV causes a generally mild, often asymptomatic, acu...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/422A61K31/7056A61K38/21
CPCA61K31/422A61K31/7056A61K38/21A61K38/212A61K2300/00A61P1/16A61P31/14A61P43/00
Inventor ETTE, ENEALAM, JOHN J.KAUFFMAN, ROBERT STEPHEN
Owner VERTEX PHARMA INC
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